Crossover Vaccination of Women Previously Randomized Into Protocol 04-C-N191

NCT01086709 | Completed

• 2 other identifiers: 99991005910-C-N059
• Study Type: observational
• Target: 5,444
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- National Cancer Institute Protocol 04-C-N191, also known as the Costa Rica Vaccine Trial, was a double-blind controlled study of the effectiveness of an experimental human papillomavirus (HPV) vaccine in preventing cervical cancer in young women in Costa Rica. Costa Rica was part of the first large study to show the association between HPV and cervical cancer, and the study contributed greatly to the understanding of this association. The women who have participated in the vaccine trial in Costa Rica are reaching the end of the follow-up period offered in the vaccine trial protocol, and as a result they are being offered the chance to have complementary vaccinations against HPV, hepatitis A, and hepatitis B. Objectives:

• To offer participants in the Costa Rica Vaccine Trial the vaccine that they did not receive during the masked portion of the trial (HPV vaccine or hepatitis A vaccine) and hepatitis B vaccination.
• To collect information about exposure to known and suspected risk factors for HPV infection and cervical cancer from women who are receiving vaccination against HPV at crossover. Eligibility: \- Women who participated in National Cancer Institute Protocol 04-C-N191. Design:
• All participants will be offered vaccination against hepatitis B.
• Women who received the hepatitis A vaccine during the trial will be offered vaccination against HPV.
• Women who received the HPV vaccine during the trial will be offered vaccination against hepatitis A.
• Appropriate vaccinations (including a combined hepatitis A and hepatitis B vaccine) will be available to reduce the number of injections that participants will be asked to receive.
• All vaccines will be given according to the manufacturer's specifications for appropriate length of time between vaccine doses.

Conditions

Cervical Neoplasia; HPV Infections

Keywords

Human Papillomavirus; Vaccine; Crossover; Hepatitis A; Hepatitis B

Eligibility Criteria

• Age: 21 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participation Status: Women previously randomized into the HPV-16/18 vaccine trial 04-C-N191, also known as the Costa Rica Vaccine Trial.
• Planned Residence: Residents of Guanacaste or Puntarenas Province or willingness to visit one of the study clinics for participation.
• Consent: Written informed consent obtained prior to enrollment into the crossover protocol.

You may not qualify if:

• The following criteria will be checked for all potential participants at the time of enrollment. If any apply, the participant will not be included in the study.
• History of (a) allergic reaction (e.g., difficulty breathing) after receipt of any vaccine, (b) hypersensitivity to latex.
• History of vaccine related adverse events during the vaccination phase that, at the discretion of the investigators, preclude vaccination during the crossover phase.
• Are receiving vaccination with Cervarix , are sexually experienced and of childbearing potential (i.e., not surgically sterilized), and are unwilling to use an effective method of birth control for 30 days before vaccination until 60 days after the last Cervarix vaccination (approximately 9 months). Acceptable forms of birth control include abstinence, surgical sterilization, hormonal contraceptives (e.g., oral, injectable, implant, and patch), intrauterine devices, and diaphragm or condom.
• History of chronic condition that per attending doctor opinion precludes her from receiving vaccination (e.g., no proper treatment available or participant is unwilling to stay under proper treatment).
• The participant has a diagnosed autoimmune illness (per the specific requirement of the INCIENSA IRB).
• The vaccine or vaccines the participant is interested in receiving are contraindicated in her case.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Proyecto Epidemiologico Guanaste (PEG)

San José, Costa Rica

Location

Related Publications (4)

• Reeves WC, Brinton LA, Garcia M, Brenes MM, Herrero R, Gaitan E, Tenorio F, de Britton RC, Rawls WE. Human papillomavirus infection and cervical cancer in Latin America. N Engl J Med. 1989 Jun 1;320(22):1437-41. doi: 10.1056/NEJM198906013202201.

  PMID: 2541336 BACKGROUND

• Herrero R, Brinton LA, Reeves WC, Brenes MM, Tenorio F, de Britton RC, Gaitan E, Garcia M, Rawls WE. Invasive cervical cancer and smoking in Latin America. J Natl Cancer Inst. 1989 Feb 1;81(3):205-11. doi: 10.1093/jnci/81.3.205.

  PMID: 2536087 BACKGROUND

• Herrero R, Schiffman MH, Bratti C, Hildesheim A, Balmaceda I, Sherman ME, Greenberg M, Cardenas F, Gomez V, Helgesen K, Morales J, Hutchinson M, Mango L, Alfaro M, Potischman NW, Wacholder S, Swanson C, Brinton LA. Design and methods of a population-based natural history study of cervical neoplasia in a rural province of Costa Rica: the Guanacaste Project. Rev Panam Salud Publica. 1997 May;1(5):362-75. doi: 10.1590/s1020-49891997000500005.

  PMID: 9180057 BACKGROUND

• Panagiotou OA, Befano BL, Gonzalez P, Rodriguez AC, Herrero R, Schiller JT, Kreimer AR, Schiffman M, Hildesheim A, Wilcox AJ, Wacholder S; Costa Rica HPV Vaccine Trial (CVT) Group (see end of manuscript for full list of investigators). Effect of bivalent human papillomavirus vaccination on pregnancy outcomes: long term observational follow-up in the Costa Rica HPV Vaccine Trial. BMJ. 2015 Sep 7;351:h4358. doi: 10.1136/bmj.h4358.

  PMID: 26346155 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections; Hepatitis A; Hepatitis B

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Blood-Borne Infections; Hepadnaviridae Infections

Study Officials

• Allan Hildesheim, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2010
• First Posted: March 15, 2010
• Study Start: January 27, 2010
• Study Completion: March 17, 2015
• Last Updated: April 5, 2018

Record last verified: 2015-03-17

Locations

CO (1)